2007版《药品注册管理办法》的实施与地方药品审评

Implemention of 2007 Drug Registration Regulation And the Drug Evaluation in Provience

通过分析对比2007-10-01实施的《药品注册管理办法》与原《药品注册管理办法》对应条款之间的异同,以期阐述地方药品审评部门的工作重点及面临的挑战。

The paper expatiated the keystones and challenges of local Drug Evaluation Center through analyzing the difference of corresponding articles between the valid ＂ Drug Registration Regulation＂ which was implemented on October 1, 2007 and the former version which was implemented in 2005.